The FLaME Cognitive Rehabilitation Study for Childhood Brain Tumour

Summary

Medical treatments have improved survival rates for children with brain tumours. However, most children experience long-term difficulties with 'cognition' (thinking skills such as memory and paying attention) and cognitive fatigue (excessive mental tiredness) after treatment. Thinking difficulties and fatigue can affect a child's ability to learn, and their social and emotional wellbeing. National guidance recommends treatment called 'cognitive rehabilitation' which teaches skills to improve or manage cognitive difficulties. Families often request this, but it is not usually available due to little research. Fatigue may also get in the way of children using and benefiting from cognitive rehabilitation. No research study has offered a fatigue treatment for children recovering from brain tumours. The study aims to see if it is practical and helpful to families to provide cognitive rehabilitation for children affected by brain tumours. The treatment focuses on strategies to help cognition. The investigators will see if adding strategies to manage fatigue helps. The study will include thirty-six 7-17-year-olds who have been treated for brain tumour at Great Ormond Street Hospital. All participants will have had an assessment describing cognitive strengths and weaknesses as part of usual care. Participants will be randomly allocated to one of three groups: 1) cognitive rehabilitation with fatigue management (12 weeks), 2) cognitive rehabilitation only (6 weeks), or 3) usual care. Each child and their carer will complete questionnaires before, during, and after the treatment, and an interview at the end of the treatment. This information will help the researchers see if families find the treatment helpful and practical to take part in, and if adding fatigue strategies is beneficial. Researchers will look at information such as the number of appointments attended, feedback about the treatment, and information about fatigue levels, cognition, and wellbeing. The findings will be used to develop a UK-wide study.

Conditions

• Childhood Brain Tumor
• Childhood Brain Tumors
• Pediatric Brain Neoplasms
• Pediatric Brain Tumor

Interventions

BEHAVIORAL

THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Full intervention

A novel strategy-based cognitive rehabilitation intervention that can be delivered with or without cognitive fatigue management. Skills are targeted sequentially based on a developmental hierarchical model where cognitive fatigue can be addressed first, followed by adult-supported compensatory strategies, with independent use of strategies for specific impairments delivered only once these earlier levels have been addressed. The 'FLaME' program incorporates strategies that have been trialled and found successful in fatigue (e.g., pacing and activity scheduling) and cognitive rehabilitation (e.g., chunking, elaborative encoding techniques) interventions for children. The intervention address two key issues: 1) to deliver strategy-based cognitive rehabilitation as an alternative to prevailing drill-based approaches, and 2) to integrate fatigue management to improve feasibility and acceptability of cognitive rehabilitation. This arm include the full intervention.

BEHAVIORAL

THE FATIGUE, LEARNING, AND MEMORY ENRICHMENT (FLaME) INTERVENTION - Cognitive rehabilitation only

A novel strategy-based cognitive rehabilitation intervention that can be delivered with or without cognitive fatigue management. Skills are targeted sequentially based on a developmental hierarchical model where cognitive fatigue can be addressed first, followed by adult-supported compensatory strategies, with independent use of strategies for specific impairments delivered only once these earlier levels have been addressed. The 'FLaME' program incorporates strategies that have been trialled and found successful in fatigue (e.g., pacing and activity scheduling) and cognitive rehabilitation (e.g., chunking, elaborative encoding techniques) interventions for children. The intervention address two key issues: 1) to deliver strategy-based cognitive rehabilitation as an alternative to prevailing drill-based approaches, and 2) to integrate fatigue management to improve feasibility and acceptability of cognitive rehabilitation. This arm includes the cognitive rehabilitation only.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Success Charity

  collaborator UNKNOWN

• Child Brain Injury Trust

  collaborator UNKNOWN

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• The UCL Great Ormond Street Institute of Child Health

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  lead OTHER

Principal Investigators

• Charlotte P Malcolm, DClinPsy · Great Ormond Street Hospital for Children NHS Foundation Trust

• Faraneh Vargha-Khadem, PhD · Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-10

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United Kingdom

Study Locations